About this Manual P/N: 01.54.458432 MPN: 01.54.458432014 Release Date: April 2021 © Copyright EDAN INSTRUMENTS, INC. 2019-2021. All rights reserved. Statement This manual will help you understand the operation and maintenance of the product better. It is reminded that the product shall be used strictly complying with this manual. User’s operation failing to comply with this manual may result in malfunction or accident for which EDAN INSTRUMENTS, INC. (hereinafter called EDAN) cannot be held liable.
WARNING A WARNING label advises against certain actions or situations that could result in personal injury or death. CAUTION A CAUTION label advises against actions or situations that could damage equipment, produce inaccurate data, or invalidate a procedure. NOTE A NOTE provides useful information regarding a function or a procedure.
Table of Contents Chapter 1 Introduction...................................................................................................1 1.1 Product Information..............................................................................................1 1.1.1 Product Overview .......................................................................................1 1.1.2 Indications for Use/Intended Use................................................................1 1.1.3 Features & Benefits ..........
.4 Pharmaceutical Study ........................................................................................38 5.5 VCG and SAECG...............................................................................................38 5.6 HRV ...................................................................................................................38 Chapter 6 Editing ECGs...............................................................................................39 6.1 ECG View ......................
A1.2 Environment Specifications .............................................................................68 A1.3 Physical Specifications ....................................................................................69 A1.4 Power Supply Specifications ...........................................................................69 A1.5 Performance Specifications.............................................................................69 Appendix 2 EMC Information ...................................
iSE Series Electrocardiograph User Manual Introduction Chapter 1 Introduction 1.1 Product Information 1.1.1 Product Overview The iSE series electrocardiograph features intuitive user interface with simple workflow, clinical-quality ECG recorder, and convenient design. For more features, see section 1.1.3 Features & Benefits. The device consists of the following components: main unit, ECG cable, electrodes, electrode adapters, power cord and power adapter, battery, and iSE software.
iSE Series Electrocardiograph User Manual Introduction 2. This system is not intended for home use. 3. This system is not intended for treatment or monitoring. 4. This system is intended for use on adult and pediatric patients only. 5. The results given by the system should be examined based on the overall clinical condition of the patient, and they cannot substitute for regular checking. 1.1.3 Features & Benefits Fingerprint Access Log in to the electrocardiograph easily and quickly.
iSE Series Electrocardiograph User Manual 1 Camera Introduction Reserved. Indicates power usage in different colors: Blue: the electrocardiograph is powered by battery. 2 Green: the electrocardiograph is connected to AC power. Or when the electrocardiograph is connected to both the battery and AC power, the battery is full. Power light Orange: the electrocardiograph is connected to both the battery and AC power, and the battery is recharging.
iSE Series Electrocardiograph User Manual Introduction 7 2 1 3 4 5 6 Name Description Pull down the switch to open the paper tray. To close the tray, close the door directly. 1 Paper tray switch NOTE: This is only applicable to electrocardiographs with thermal printer. 2 Mains AC power 3 LAN port 4 USB interface 5 Connects the system to an AC power supply via power cable. Connect to a LAN cable. Connect to your keyboard, mouse, U disk, USB printer, and code scanner.
iSE Series Electrocardiograph User Manual Introduction 1 2 Name Description 1 Paper tray (option) 2 Handle (option) Contains thermal chart paper roll. / Figure 5 Right 1 Name 1 ECG cable socket 2 DE18 socket 3 Fingerprint identifier 2 3 4 Description Connects to the ECG cable. Connects to the DE18 connection cable. Identifies user fingerprint electrocardiograph. for login to the To power on, press and hold the On/Off button 4 On/Off button when the device is off.
iSE Series Electrocardiograph User Manual Introduction Press and hold the button. A menu pops up, providing the following options: restart, power off, and screenshot. To enable power-save, gently press the button. Figure 6 Bottom 1 2 3 1 2 3 Name Description Battery Contains a battery to supply power when the unit is not connected to AC power. Battery Pull the switch left to make the battery pop out. compartment switch Product label Contains product information. 1.1.
iSE Series Electrocardiograph User Manual Submenu Introduction Description Patient Displays patients that have ordered an ECG test and contains a number of operations you can perform on patient information. ECG File Stores ECGs that have been recorded and contains a number of operations you can perform on ECGs. System Setting STAT ECG EDAN Cloud Review or change system settings. STAT mode bypasses patient data entry. A temporary ID number is assigned to the patient to identify stat tests.
iSE Series Electrocardiograph User Manual Introduction Room No. Name Age Outp./Inp./PE ID ECG Test Department Button/Icon Description Return to the Main Menu. Display the on-screen number of patients to be tested. This number updates in real time. This icon provides the following options: sequence setting, filtering setting, download setting, and order server. Switch to another user account. This button is visible when user login is enabled in system setting > user setting.
iSE Series Electrocardiograph User Manual Introduction Activate iSE’s infrared scanner to scan the barcode so as to retrieve the Outpatient / Inpatient / PE ID. Tap this icon again to stop scanning. Download the specific patient information from the PC. You need to enter the default key word for order querying so that the information with the order can be downloaded. For details, see section 4.3 Retrieving Orders from Server. Disable the filter when it is used to filter the patient information. STAT ECG.
iSE Series Electrocardiograph User Manual Introduction Start or stop ECG recording. NOTE: iSE can record up to 1,800-second ECGs. Re-acquire ECGs. Auto Recording mode, including Auto and Manual. Tap on it to toggle between the two modes. In the Auto mode, the system will acquire ECGs at the set time and then print a report. If the user stop recording before the time, the system will print the last 10s of ECG.
iSE Series Electrocardiograph User Manual Button/Icon Introduction Description Search for ECGs that have been recorded. Enter the key word for search and the system will display the ECGs that meet the criteria. Fuzzy search is supported. Filter ECGs. You can filter ECGs by using the criteria such as uploaded or not, diagnosed or not, printed or not, and the exam time. Retrieve diagnosis. You can get from server the latest ECG measurements and diagnosis for all ECG files in this tab.
iSE Series Electrocardiograph User Manual Introduction Modify the patient information of an ECG file. You can modify all patient information except ID and exam item. Press and hold an ECG file. This button will appear. Edit NOTE: If patient information such as names or gender are modified, the information elsewhere with the same ID number will be updated. Sync Urgent Retrieve diagnosis and doctor’s signature for an ECG file. Press and hold an ECG file. This button will appear.
iSE Series Electrocardiograph User Manual Introduction Connect to electrocardiograph Connect to electrodes ECG cable Lead wires Figure 12 DE18 sampling box, DE18 cable, and lead wires Connect to electrocardiograph Connect to DE18 sampling DE18 cable DE18 sampling box, Cable connector Electrode connector 1.1.7 Symbols No.
iSE Series Electrocardiograph User Manual Introduction 4 Consult operating instructions 5 Near-field communication 6 USB interface 7 SIM and SD cards slot (two-in-one) 8 Computer network 9 On/Off switch 10 General symbol for recovery/recyclable 11 Part Number 12 SERIAL NUMBER 13 Date of manufacture 14 MANUFACTURER 15 AUTHORISED REPRESENTATIVE EUROPEAN COMMUNITY 16 CE marking 17 Disposal method - 14 - IN THE
iSE Series Electrocardiograph User Manual Introduction Caution: Federal (U.S.) law restricts this device to sale by or on the order of a physician.
iSE Series Electrocardiograph User Manual Introduction 2. The right angle bracket “>” is a concise method to indicate a sequence of menu selections. 3. *: Apply to devices with wireless functions. 1.2 Safety Information This section provides important safety information related to the use of iSE.
iSE Series Electrocardiograph User Manual Introduction 9. The disposable electrodes can only be used for one time. 10. Do not touch the patient, bed, table or the equipment while using the ECG together with a defibrillator. 11. Do not touch accessible parts of electrical equipment and the patient simultaneously. 12.
iSE Series Electrocardiograph User Manual Introduction provided by medical electrical equipment complying with IEC/EN 60601-1, and b) Outside the patient environment, the level of safety appropriate for non-medical electrical equipment complying with other IEC or ISO safety standards. 19. All the accessories connected to system must be installed outside the patient vicinity, if they do not meet the requirement of IEC/EN 60601-1. 20.
iSE Series Electrocardiograph User Manual Introduction a) this device may not cause harmful interference, and b) this device must accept any interference received, including interference that may cause undesired operation. 32.This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation.
iSE Series Electrocardiograph User Manual Introduction To ensure the patients’ safety and protect their personal health information, the user should implement practices or measures that include: 1. Physical safeguards - physical safety measures to ensure that unauthorized personnel do not have access to the device. 2. Operational safeguards - safety measures during operation. 3. Administrative safeguards - safety measures in management. 4. Technical safeguards - safety measures in technical field.
iSE Series Electrocardiograph User Manual Introduction suggested to build a VLAN, assign the LAN ports where the approved switch port and electrocardiograph are into the same VLAN, and isolate it from other VLANs. 9. When the electrocardiograph is returned for maintenance, disposed of, or removed from the medical institution for other reasons, it is necessary to ensure that all patient data are removed from the electrocardiograph. 10.
iSE Series Electrocardiograph User Manual Introduction installing the battery. 4. Do not heat or splash the battery or throw it into fire or water. 5. Do not destroy the battery; do not pierce battery with a sharp object such as a needle; do not hit with a hammer, step on or throw or drop to cause strong shock; do not disassemble or modify the battery. 6. When leakage or foul smell is found, stop using the battery immediately.
iSE Series Electrocardiograph User Manual Introduction recycling of this product or battery, please contact your local Civic Office, or the shop where you purchased the product. 5. Federal (U.S.) law restricts this device to sale by or on the order of a physician.
iSE Series Electrocardiograph User Manual Setting Up the Electrocardiograph Chapter 2 Setting Up the Electrocardiograph WARNING The equipment, patient cable and electrodes should be checked before use. Replace them if there is any evident defectiveness or aging that may impair the safety or the performance, and make sure that the equipment is in proper working condition. 2.
iSE Series Electrocardiograph User Manual Setting Up the Electrocardiograph The patient should not come into contact with conducting objects such as earth, metal parts etc. Ensure that the patient is warm and relaxed, and breathes calmly. 2.2 Connecting the ECG Cable 1. Connecting to the electrocardiograph In the case of DE12, connect the ECG cable to the socket on the right side of the electrocardiograph. Secure with two screws. (See Figure 11.
iSE Series Electrocardiograph User Manual Setting Up the Electrocardiograph 1. Slide the top of the iSE screen down. The notification bar is displayed 2. Turn the WLAN on. WIFI paring starts. 3. Select the printer model for paring. Enter the password to activate the printer. 4. Select Print and Storage Setting > Recording Device > External Printer. 5. Select Print via App before you print an ECG. To connect an external printer with infrastructure WIFI: 1. Slide the top of the iSE screen down.
iSE Series Electrocardiograph User Manual Setting Up the Electrocardiograph been fully recharged but its continuous use is greatly reduced, replace the battery. CAUTION 1. If the electrocardiograph is turned off because of low battery capacity or unexpected power failure, the settings configured or the ECGs being recorded may not be saved. 2. The electrocardiograph cannot print an ECG report when the battery has low capacity. 3.
iSE Series Electrocardiograph User Manual Setting Up the Electrocardiograph Using fingerprint (if enrolled before) Tap Fingerprint Identification. Press your finger on the fingerprint reader on the right side of iSE. Using user account and password Enter your user name and password. Tap Log in. No matter which way you choose, the Patient tab will open after login. NOTE: Do not run other applications if available when running iSE, otherwise the system response will slow down. 2.
iSE Series Electrocardiograph User Manual Preparing the Patient Chapter 3 Preparing the Patient 3.1 Instructing the Patient Before attaching the electrodes, greet the patient and explain the procedure. Explaining the procedure decreases the patient’s anxiety. Reassure the patient that the procedure is painless. Privacy is important for relaxation. When possible, prepare the patient in a quiet room or area where others can’t see the patient. Make sure that the patient is comfortable.
iSE Series Electrocardiograph User Manual Electrodes IEC AHA C1 V1 Preparing the Patient Locations Fourth intercostal space at the right border of the sternum White/Red Brown/Red C2 V2 Fourth intercostal space at the left border of the sternum White/Yellow Brown/Yellow C3 V3 White/Green Brown/Green C4 V4 White/Brown Brown/Blue C5 V5 White/Black Brown/Orange C6 V6 White/Violet Brown/Violet L LA Yellow Black R RA Red White F LL Fifth rib between C2 and C4 Fifth intercost
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iSE Series Electrocardiograph User Manual Green Red N RL Black Green Preparing the Patient Right leg Figure 14 C3R+C4R +C5R (Right) Electrodes IEC AHA C3R V3R White/Pink Brown/Yellow C4R V4R White/Gray Brown/Red C5R V5R White/Green Brown/Green Locations Right anterior chest opposite of C3 Right anterior chest opposite of C4 Right anterior chest opposite of C5 Figure 15 C7+C8+C9 (Back) - 31 -
iSE Series Electrocardiograph User Manual Preparing the Patient Electrodes Locations IEC AHA C7 V7 Left posterior axillary line on the same horizontal level as C4 and C6 White/Orange Brown/Black C8 V8 Left midscapular line on the same horizontal level as C4 and C7 White/Blue Brown/Blue C9 V9 White/Yellow Left paraspinal border on the same horizontal level Brown/Yellow as C4 and C8 Attaching Electrodes 1. Ensure that the electrodes are clean. 2.
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iSE Series Electrocardiograph User Manual Entering Patient Information Chapter 4 Entering Patient Information 4.1 Manually Entering Patient Information Tap in the Patient tab. New Patient window will open. Enter patient information, select an ECG test and set the priority. Tap Save. The patient is available now in the Patient tab. If you want to record an ECG immediately after you enter the information, turn Sample now on in the New Patient window.
iSE Series Electrocardiograph User Manual Entering Patient Information a) Turn Order Retrieve on. b) Select the Default key word for order querying from the drop-down menu. c) Type the Order Date, Department, or Exam Room as appropriate. d) If needed, configure these settings: Auto Download and the downloading interval, Check patient information before ECG sampling, Order Date, Department, Exam Room. e) When finished, tap OK. 3. Single download: Tap and the New Patient window opens.
iSE Series Electrocardiograph User Manual Entering Patient Information Tap and hold the patient information you want to modify. Select Edit from the pop-up menu. When finished, tap OK to save your modification. Or you can tap Cancel to cancel your modification. To delete patient information: Tap and hold the patient information you want to delete. Select Delete from the pop-up menu. The selected one is deleted. Alternatively, tap in the Patient tab.
iSE Series Electrocardiograph User Manual Entering Patient Information 3. Enter the sorting criteria, e.g. Outp./Inp./PE ID, name, request ID etc. Tap OK. 4. Patient information that meets the criteria is displayed. To cancel sorting, tap . Patient information before sorting is displayed. To queue patient information: 1. Tap in the Patient tab. Select Sequence Setting from the pop-up menu. 2. Configure the setting. The queuing criteria include order date and patient name.
iSE Series Electrocardiograph User Manual Recording an ECG Chapter 5 Recording an ECG The method for recording an ECG varies depending on the type of ECG to be recorded. This chapter describes how to record the following ECG types: standard ECG (including rhythm ECG), pharmaceutical study, VCG and SAECG, and heart rate variability (HRV). Except standard ECG, the other methods need to be purchased and enabled. Standard ECG acquisition is classified into real-time sample and pre-sample.
iSE Series Electrocardiograph User Manual Recording an ECG To carry out pre-sample recording: 1. Select System Setting > Sampling Setting > Sampling Mode > Pre-sample. 2. Tap . ECG recording screen opens. The system automatically checks if 10s ECG has been acquired. If no, the system will continue to acquire ECG till reaching 10s. If yes, the system records and analyzes the ECG. NOTE: Gain, filter, and speed are not allowed to change during ECG recording. To change the lead configuration e.g.
iSE Series Electrocardiograph User Manual Editing ECGs Chapter 6 Editing ECGs The system can be configured to automatically analyze ECGs after recording. To manually activate ECG data analysis, tap an ECG in the ECG File tab. Then the ECG Analysis screen is displayed. In this screen, you can edit, measure, diagnose, and compare ECGs. The analysis screen is varied according to the ECG type. The following figure shows the analysis screen of standard ECG as an example.
iSE Series Electrocardiograph User Manual Editing ECGs 6.2 ECG Measurement/Diagnosis Manual Measurement To measure ECG waveform, open the waveform magnification page, and tap on the icon in the right lower corner. A measurement pane will be displayed. Tap once more to exit measurement. To move the measurement pane, slide it. To move the four pane lines, tap on one line and slide it. Slide up and down to measure amplitude (in mV), and left and right to measure interval (in ms).
iSE Series Electrocardiograph User Manual Editing ECGs 2 ○ 1 3 Averages thumbnail The averaged complexes of standard leads and ALL are displayed. Slide the thumbnail to switch from one lead to another. Tap on one lead to display its magnified averages in○ 2 . ○ 2 Magnified averages There are six measurement lines matching six measurement points. They are P1 (onset of P wave), P2 (offset of P wave), Q (onset of QRS complex), S (offset of QRS complex), T1 (onset of T wave), and T2 (offset of T wave).
iSE Series Electrocardiograph User Manual QRS (ms) Editing ECGs QRS complex duration Q-T interval / Normalized QT interval For calculation of QTc, select System Setting > Parameter QT/QTc (ms) Setting > QTc Formulas. The default formula is Bazett. You can change the formula, but this takes effect only for the ECG analysis done after this change.
iSE Series Electrocardiograph User Manual Editing ECGs 1. Open the Analysis screen. 2. Tap . Select E-record from the menu. 3. You can review the patient’s electronic medical records from the server. 6.6 Comparing ECGs iSE allows you to compare ECGs with the same patient ID. 1. Open the Analysis screen. 2. Tap . Select Compare from the menu. 3. Select the ECGs you want to compare from the pop-up window. 4. Tap Compare. You can compare the ECG waveforms or averaged complexes.
iSE Series Electrocardiograph User Manual Printing an ECG Report Chapter 7 Printing an ECG Report To preview, print and share an ECG report, tap Preview, Print, or Share from the menu. in the Analysis screen. Select You can choose thermal printer (if configured) or external printer. In the case of thermal printer, the system will automatically print an ECG report.
iSE Series Electrocardiograph User Manual Transmitting and Exporting ECGs Chapter 8 Transmitting and Exporting ECGs To transmit ECGs to server: 1. Configure SFTP server in System Setting > Transmission Setting > Server Setting. 2. Open ECG File tab. 3. Tap . Select the ECGs you want to transmit. Or tap Select All to select all the ECGs. 4. Tap again to upload the ECGs to the server. NOTE: Do not talk on the phone or send messages when you are using your 4G card for ECG upload.
iSE Series Electrocardiograph User Manual Deleting ECGs Chapter 9 Deleting ECGs To delete ECGs: 1. Open the ECG File tab. 2. Tap . Select the ECG report(s) you want to delete. Or tap Select All to select all the ECGs. 3. Tap again. The following message is displayed: Are you sure to delete the data? 4. Do one of the following: • To delete the selected ECG report (s), tap OK. • To cancel the deletion and select different reports, tap Cancel.
iSE Series Electrocardiograph User Manual System Setting Chapter 10 System Setting To set up the iSE system, tap System Setting in the Main Menu. Options underlined are default settings. In each setting window, you need to tap Save if available to save your changes. 10.1 Sampling Setting Item Description Sampling Mode Choose from: Real-time sampling or Pre-sampling Select Pre-sample to initiate the acquisition of ECG data before you tap . The latest 10 seconds of ECG data will be recorded.
iSE Series Electrocardiograph User Manual Electrode Hint Intelligent Detection System Setting in the opposite position. The default setting is On. Pace If selected, the system asks you if to display the pacing spike or not when it detects a pacemaker pulse. NOTE: This option is applicable to the Auto mode of standard ECG. 10.2 Patient Information Setting Item Description Patient Source ID Choose from: Inpatient ID, Outpatient ID, Physical Examination ID.
iSE Series Electrocardiograph User Manual System Setting Ward Not selected by default. Department Selected by default. Room No. Selected by default. Request ID Selected by default. Exam Room Selected by default. Exam Item Selected by default. Technician Not selected by default. Physician Selected by default. Clinical Diagnosis Not selected by default. Priority Selected by default. Medical History Not selected by default. Height/Weight Choose from: Off, cm/kg, inch/lb.
iSE Series Electrocardiograph User Manual System Setting In DICOM (Encapsulated PDF) files and DICOM (ECG Waveform) files, the value of QTc is always calculated by the Bazzet formula. Choose from: On, Off. External storage is forbidden Report Format Choose from: Pediatric mode: 3x3, 6+3, 9x1 12-lead: 3x4+1R, 6x2+1R, 12x1. 15-lead: 3x5+1R, 6+9, 15x1 18-lead: 6x3+1R, 18x1 NOTE: In the case of external printer, only the default report formats are available. Choose from: Sequential, Simultaneous.
iSE Series Electrocardiograph User Manual Report System Setting addition to an automatic ECG printout. VCG (visible when activated. Settings are displayed according to the functions activated.) Record Time Choose from: 10s, 1 min, 3 min, 5 min. Report Type Choose from: VCG Report, TVCG Report, SAECG Report. X/Y/Z Wave Choose from: Off, On. If On, print X, Y, and Z waves on the VCG report. Analysis Choose from: Off, On. If On, print the diagnosis on the VCG and SAECG report.
iSE Series Electrocardiograph User Manual System Setting 10.4 Filter Setting Item Description Baseline Filter ECG traces can contain some baseline wander caused by movement. You can reduce this wander of the baseline by applying a baseline filter. When you use this filter, the recorded signal is not changed. Choose from: 0.01Hz, 0.05Hz, 0.32Hz or 0.67Hz. This setting is the lower limit of the frequency range. The higher the settings, the more the filter smooths out wandering baseline.
iSE Series Electrocardiograph User Manual System Setting the server. Time Synchronization Choose from: On, Off. When On, the system will send a synchronization request to the server each time the electrocardiograph is powered on or retrieves orders from server. And the time sent by the server is taken as the current system time. Encrypted Transmission Choose from: On, Off. When On, the system will use encryption protocol during ECG transmission.
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iSE Series Electrocardiograph User Manual Item Description Axis calculation method Choose from: Area Method or Amplitude Method. Tachycardia (greater than) Enter a heart rate. The default value is 100 bpm. Bradycardia (less than) Enter a heart rate. The default value is 60 bpm. P Wave Normal Duration Choose from: 110ms or 120ms. System Setting When the P wave duration exceeds this setting, system will prompt you P wave widens. Algorithm Sensitivity Choose from: Normal or Weak.
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iSE Series Electrocardiograph User Manual System Setting Item Description User Login If selected, you have to enter user name and password for login to iSE. You can also input the user’s fingerprint for login. User login is selected by default. Add User Enter the user’s real name, define his/her user name and password, and (or) input his/her fingerprint for login to iSE. The user can also be given the authority to diagnose by ticking the check box before diagnostic authority.
iSE Series Electrocardiograph User Manual System Setting and upload ECG data to the server. Administrator Password Define the password required to access System Setting, the Patient tab (if selected), and ECG File tab (if selected). Blank by default. Enter up to 6 letters or numbers or combination of them to define the password. Restore default factory settings Clears the current settings and returns to the default factory settings. You need to enter the password to configure this setting.
iSE Series Electrocardiograph User Manual System Message Chapter 11 System Message System messages and the corresponding causes are listed below. Table 11-1 System messages and causes System Message Causes Lead off: Electrodes fall off the patient or the lead wires are disconnected to the ECG sampling box. Network unavailable! 4G, WIFI, and Ethernet are off. Network connection timeout! Please check the network. The network signal is poor and network connection is failed.
iSE Series Electrocardiograph User Manual Cleaning, Care and Maintenance Chapter 12 Cleaning, Care and Maintenance Use only the EDAN-approved substances and methods listed in this chapter to clean or disinfect your equipment. Warranty does not cover damage caused by using unapproved substances or methods. Edan Instruments has validated the cleaning and disinfection instructions provided in this User Manual.
iSE Series Electrocardiograph User Manual Cleaning, Care and Maintenance 12.2 Cleaning WARNING 1. Before cleaning, unplug the electrocardiograph from AC power if connected. Disconnect with the ECG cables. If the device or accessories has been in contact with the patient, clean and disinfect them after each use. 1. Power off the device. Take out its battery. In the case of DE18 sampling box, disconnect it from the DE18 cable and the lead wires. 2.
iSE Series Electrocardiograph User Manual Cleaning, Care and Maintenance 2. Wipe the exterior of the device and accessories, including the main unit, DE18 sampling box, ECG cable, reusable electrodes and etc., using a soft cloth dampened with diluted disinfectant. 3. Remove the remaining disinfectant if appropriate with a dry cloth. 4. Air dry the main unit/sampling box/ECG cable/reusable electrodes for at least 30 minutes in a ventilated and cool place.
iSE Series Electrocardiograph User Manual Cleaning, Care and Maintenance 12.4.1 Recharging and Replacing the Battery Recharging the battery iSE series electrocardiograph is equipped with a recharge control circuit together with the battery. Because of consumption during storage and transportation, the battery capacity decreases. Recharge the battery prior to the first use. When the unit is connected to the mains supply, the battery will be recharged automatically.
iSE Series Electrocardiograph User Manual Cleaning, Care and Maintenance disposal and recycling. 4. Remove the battery from the electrocardiograph that is not in use for a long time. 5. If the battery is not used for a long time, we recommend that the battery be recharged at least once every 6 months to prevent over-discharge. 12.4.2 Thermal Chart Paper Tips for handling thermal paper: Store in a dry, dark and cool place. Avoid exposure to excessive temperature, humidity and sunshine.
iSE Series Electrocardiograph User Manual Cleaning, Care and Maintenance The following safety checks should be performed at least every 12 months by a qualified person who has adequate training, knowledge, and practical experience to perform these tests. a) Inspect the equipment and accessories for mechanical and functional damage. b) Inspect the safety related labels for legibility. c) Inspect the fuse to verify compliance with the rated current and circuit-breaking characteristics.
iSE Series Electrocardiograph User Manual Cleaning, Care and Maintenance shaking them violently when moving to another place. Prevent any liquid from seeping into the equipment; otherwise the safety and the performance of the electrocardiograph and sampling box cannot be guaranteed. ECG cable Integrity of the ECG cable, including the main cable and lead wires, should be checked regularly. Make sure that it is conductible. Do not drag or twist the ECG cable with excessive stress.
iSE Series Electrocardiograph User Manual Accessories Chapter 13 Accessories WARNING Only the ECG cable and other accessories supplied by the manufacturer can be used. Or else, their performance and electric shock protection cannot be guaranteed. Table 13-1 Standard accessory list Accessory Power Cord Power Cord Model FG-L23X-20150323-001 Part Number 01.13.037122 FG-L23X-003-04 01.13.036638 EC10DIBDS1A 01.57.471500 EC10DISDS2 01.57.107581 EC10DIGDS1 01.57.107583 CI-0001 01.57.
iSE Series Electrocardiograph User Manual Switching Power Adaptor Accessories ECG-EJ01 01.57.040169 UE48-190253SPA3 21.21.064244 Table 13-2 Optional accessory list Accessory Model Part Number H99SG 01.57.471858 H124SG 01.57.471859 L-00-S 01.57.471860 Medi-Trace 200 01.57.471862 Q-Trace Gold5500 01.57.471863 Electrode Adapters 98ME07GA454 01.57.040172 Socket Adapters CK-03-752 01.57.471864 Thermal Chart Paper / 01.57.472015 SD Card / 01.17.
iSE Series Electrocardiograph User Manual Warranty and Service Chapter 14 Warranty and Service 14.1 Warranty EDAN warrants that EDAN’s products meet the labeled specifications of the products and will be free from defects in materials and workmanship that occur within warranty period. The warranty is void in cases of: a) Damage caused by mishandling during shipping. b) Subsequent damage caused by improper use or maintenance. c) Damage caused by alteration or repair by anyone not authorized by EDAN.
iSE Series Electrocardiograph User Manual Technical Specifications Appendix 1 Technical Specifications A1.
iSE Series Electrocardiograph User Manual Technical Specifications Relative Humidity: 15%RH~95%RH Non-Condensing 15%RH~95%RH Non-Condensing Atmospheric Pressure: 70 kPa ~106 kPa 70 kPa ~106 kPa A1.3 Physical Specifications No handle or thermal printer: 270mm(L)×170mm(W)×28mm(H), ±2mm Dimensions With handle: 270mm(L)×230mm(W)×52mm(H), ±2mm With thermal printer: 274mm(L)×274mm(W)×90mm(H), ±2mm 1.2 kg±0.3 kg (excluding thermal printer, handle, and printer paper) Weight 1.4 kg±0.
iSE Series Electrocardiograph User Manual Technical Specifications HR Range 30 bpm – 300 bpm Accuracy 1 bpm AC Filter: 50Hz / 60Hz / Off DFT Filter: 0.01Hz / 0.05Hz / 0.32Hz / 0.67Hz Filter EMG Filter: 25Hz / 35Hz / 45Hz / Off Lowpass Filter: 350Hz / 300Hz / 270Hz / 150Hz / 100Hz / 75Hz DE12 / DE18 Performance Leads Mode Acquisition Mode DE12: 12 standard leads DE18: 18 standard leads DE12: Simultaneously 12 leads DE18: Simultaneously 18 leads A/D: 24 bits Analog-to-Digital Converter Resolution: 0.
iSE Series Electrocardiograph User Manual Width Technical Specifications DE18: ±750 uV to ±700 mV DE12: 30 us to 2.0 ms DE18: 50 us to 2.0 ms WIFI Transmitting Frequency Frequency Band Modulation Type Transmitting Power 2.4 GHz and 5 GHz 2412 MHz – 2472 MHz (2.4GHz) 5150 MHz – 5850 MHz (5GHz) DBPSK/DQPSK/CCK BPSK/QPSK/16QAM/64QAM,GFSK,π/4-DQPSK,8-DPSK ≤17 dBm (2.
iSE Series Electrocardiograph User Manual EMC Information Appendix 2 EMC Information Electromagnetic Emissions Guidance and manufacture’s declaration - electromagnetic emission The iSE is intended for use in the electromagnetic environment specified below. The customer or the user of the iSE should assure that it is used in such an environment.
iSE Series Electrocardiograph User Manual EMC Information The iSE is intended for use in the electromagnetic environment specified below. The customer or the user of the iSE should assure that it is used in such an environment. IEC/EN 60601 Immunity test test level Electrostatic discharge (ESD) Electromagnetic environment guidance Compliance level 8 kV contact 8 kV contact 15 kV air 15 kV air Floors should be wood, concrete or ceramic tile.
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iSE Series Electrocardiograph User Manual Voltage dips, 0 % UT; 0.5 cycle short At 0°, 45°, 90°, interruptions and 135°, 180°, 225°, 270° and 315° voltage variations on power supply input lines 0 % UT; 1 cycle IEC/EN and 61000-4-11 70 % UT; 25/30 cycles ) Single phase: at 0° EMC Information 0 % UT; 0.5 cycle Mains power quality At 0°, 45°, 90°, should be that of a 135°, 180°, 225°, typical commercial or 270° and 315° hospital environment.
iSE Series Electrocardiograph User Manual EMC Information Electromagnetic Immunity Guidance and manufacture’s declaration - electromagnetic immunity The iSE is intended for use in the electromagnetic environment specified below. The customer or the user of the iSE should assure that it is used in such an environment.
no closer than 30 cm (12 inches) to Where P is the maximum output power rating of the transmitter in - 75 -
iSE Series Electrocardiograph User Manual EMC Information watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey,a should be less than the compliance level in each frequency range.b Interference may occur in the vicinity of equipment marked with the following symbol: NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
iSE Series Electrocardiograph User Manual EMC Information Table 1 Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless communications equipment Test Frequency (MHz) Brand a) (MHz) Service a) Modulation b) Maximum Power(W) Distance (m) IMMUNITY TEST LEVEL (V/m) 1.8 0.3 27 2 0.3 28 0.2 0.3 9 2 0.3 28 2 0.3 28 2 0.3 28 0.2 0.
Note: If necessary to achieve the IMMUNITY TEST LEVEL, the distance between the transmitting antenna and the ME EQUIPMENT or ME SYSTEM maybe reduce to 1m. The 1 m test distance is permitted by IEC/EN 61000-4-3.
iSE Series Electrocardiograph User Manual EMC Information a) For some services, only the uplink frequencies are included. b) The carrier shall be modulated using a 50% duty cycle square wave signal. c) As an alternative FM modulation, 50% pulse modulation at 18 Hz may be used because while it does not represent actual modulation, it would be worst case.
iSE Series Electrocardiograph User Manual EMC Information Recommended separation distances between portable and mobile RF communications equipment and the EQUIPMENT or SYSTEM Recommended separation distances between portable and mobile RF communications equipment and the iSE The iSE is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.
iSE Series Electrocardiograph User Manual Abbreviation Appendix 3 Abbreviation Abbreviation Statement LCD Liquid Crystal Display ECG Electrocardiograph/Electrocardiogram BP Blood Pressure HR Heart Rate AC Alternating Current ID Identification AC Alternating Current USB Universal Serial Bus AGC Auto Gain Control NC Normal Condition SFC Single Fault Condition NFC Near field communication PDF Portable Document Format FDA-XML Food and Drug Administration-Extensible Markup Language
Appendix 4 Installation instructions 1. The specific use scenario and installation setting diagram of the product 2.This device is fixed used and can not move by Non-professionals. 3.This device must operate with a minimum distance of 20 cm between the radiator and user body.
